Trial · NCT00549549
Outcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to Day 2 in Patient's Assessment of Pain Intensity | Baseline and Day 2 | Intent to treat (ITT): defined to be all subjects who were randomized, took at least 1 dose of study medication and had at least one post baseline evaluation; and Last Observation Carried Forward (LOCF) | Scores on a scale | MEAN |
| SECONDARY | Change From Baseline in Physician's Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Tenderness | Baseline, Day 5, Day 9, and Day 14/Early Termination | Intent to treat (defined to be all subjects who were randomized, took at least 1 dose of study medication and had at least one post baseline evaluation, ITT) and LOCF | Scores on a scale | MEAN |
| SECONDARY | Change From Baseline in Physician's Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Swelling | Baseline, Days 5, 9 and 14/Early Termination | Intent to treat (defined to be all subjects who were randomized, took at least 1 dose of study medication and had at least one post baseline evaluation, ITT) and LOCF | Scores on a scale | MEAN |
| SECONDARY | Number of Participants With Redness Present According to Physician's Assessment of the Index Joint on Day 5, Day 9, and Day 14/Early Termination | Baseline, Day 5, Day 9 and Day 14/Early Termination | Intent to treat (defined to be all subjects who were randomized, took at least 1 dose of study medication and had at least one post baseline evaluation, ITT) and LOCF | Participants | NUMBER |
| SECONDARY | Number of Participants With Warmth Present According to Physician's Assessment of the Index Joint on Day 5, Day 9, and Day 14 | Baseline, Day 5, Day 9 and Day 14 | Intent to treat (defined to be all subjects who were randomized, took at least 1 dose of study medication and had at least one post baseline evaluation, ITT) and LOCF | Participants | NUMBER |
| SECONDARY | Change From Baseline in Patient's Assessment of Pain Intensity | Baseline, Day 2 to Day 13 | Intent to treat (defined to be all subjects who were randomized, took at least 1 dose of study medication and had at least one post baseline evaluation, ITT) and LOCF | Scores on a scale | MEAN |
| SECONDARY | Change From Baseline in Patient's Assessment of Pain Intensity on Day 1 | Baseline, 2, 4, 8, 12 hours postdose Day 1, Day 2 (24 hours and 32 hours post first dose) | Intent to treat (defined to be all subjects who were randomized, took at least 1 dose of study medication and had at least one post baseline evaluation, ITT) and LOCF | Scores on a scale | MEAN |
| SECONDARY | Change From Baseline in Time Weighted Average of Patient's Assessment of Pain Intensity Over 8, 12, and 24 Hours | Baseline, 8, 12, and 24 hours post first dose | ITT and LOCF | Scores on a scale | MEAN |
| SECONDARY | Number of Participants With ≥30% and ≥50% Reduction From Baseline to Day 2 in Patient's Assessment of Pain Intensity | Baseline, Day 2 | ITT and LOCF | Participants | NUMBER |
| SECONDARY | Participant's Assessment of Pain Intensity for the Average Pain Intensity at Baseline | Baseline | ITT, LOCF | Units on a scale | MEAN |
| SECONDARY | Percentage Change From Baseline in the Patient's Assessment of Pain Intensity for the Average Pain Intensity on Days 2-4, Days 2-8 and Days 2-13 | Baseline to Day 13 | ITT, LOCF | Percentage change | MEAN |
| SECONDARY | Number of Participants With Withdrawal From Treatment Due to Lack of Efficacy | Day 1 to Day 8 | ITT | Participants | NUMBER |
| SECONDARY | Participants Global Evaluation of Study Medication Score | Day 9 | ITT | Scores on a scale | MEAN |
| SECONDARY | Number of Participants With Pre-specified Gastrointestinal (GI) Adverse Events | Baseline to Day 14/Early Termination | ITT | Participants | NUMBER |
| SECONDARY | Number of Participants With Moderate or Severe Central Nervous System (CNS) Adverse Events | Baseline to Day 14/Early Termination | ITT | Participants | NUMBER |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT00549549/outcomes